MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEMORAL HEAD 036/0MM 12/14; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 09/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).

Event Description

It was reported that the rubber foam was stuck to the tyvek of the blister package.The item fell on the floor while unpacking.The device was implanted in to the patient.No further information has been provided.

Manufacturer Narrative

(b)(4).Reported event was confirmed by photographic inspection.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DELTA CERAMIC FEMORAL HEAD 036/0MM 12/14
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 6947776
• MDR Text Key: 89342253
• Report Number: 3002806535-2017-00944
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK051411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 650-0837
• Device Lot Number: 2017051364
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 05/08/2018
• Supplement Dates FDA Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other